RE:Accelerated Approval - what are the chances?That's exactly how our Ph. 2 trial is designed.
10. Accelerated Approval (Subpart H and Subpart E) Considerations ...
In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application Source:
The new 2018 FDA guidelines, dated of Feb. 2018 Now, our study is designed just like that:
Brief Summary:
This is a phase II, open-label, single-arm, multi-center Study
Primary Outcome Measures : - Efficacy, evaluated by the Complete Response (CR) rate.
The primary endpoint of this Study is efficacy, evaluated by the Complete Response ("CR") rate in patients with Carcinoma In-Situ ("CIS") with or without resected papillary disease at 360 days post primary treatment
Source: https://clinicaltrials.gov/ct2/show/NCT03945162
You would have expected such basic perspective from analyst Uddin and FGPFUD.
So we have the good clinical trial design and now, CR%s and DR%s that can give BCG-Unresponsive patients a new alternative to cystectomy.
Up to the FDA to decide.
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Eoganacht - (12/8/2022 1:28:48 PM)
Accelerated Approval - what are the chances?
8 out of 29 patients (28%) have hit at least 450 days completely cancer free.
Remove the 12 undertreated from the calculation to see just the optimized resu ( these 12 are mostly little different from the first 3 half-dose patients from the phase 1b ) and you have these optimized results at 450 days:
8 out of 17 ( 47% ) patients cancer free (including 3 full dose phase 1 patients) and
6 out of 14 ( 43% ) patients cancer free (including only phase 2 patients)
Surely those numbers, along with the extremely high safety, should be enough for AA.
I'm sure the 6 phase 2 patients who no longer have bladder cancer think so.